You’ll learn what elements your risk management plan must include ... how to apply the plan to your products ... how to create a risk evaluation matrix ... techniques to evaluate, control and mitigate risk ... how to integrate risk management into a Quality Management System following the GHTF approach ... and more.

You’ll also dig deep into the intricacies of ISO 14971, including how it helps control and mitigate medical device risk ... how the FDA interprets it ... and its role as an
EU-harmonized standard for the MDD and IVDD.

Plus, you’ll sort out the alphabet-soup of risk evaluation tools — ETA, FMEA, FTA, HACCP, PHA and HAZOP — and come to understand each one. More important,
you’ll know how to implement the one(s) most appropriate to your own operation.

Your workshop leader will be Dan O’Leary, president of Ombu Enterprises LLC. He has spent more than 30 years in quality, operations and program management in four highly regulated industries — devices, clinical labs, aviation and defense.

He’ll enhance your training with numerous case studies that will illustrate the concept of risk and examine real-life serious events in medical device manufacturing. Plus, he’ll incorporate interactive exercises, leading you through the steps from recognizing risks all the way to assuming the role of quality auditor.

Dan O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

He is president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O’Leary has a master’s degree in mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and six sigma black belt; and is certified by APICS in resource management.

Hurry — register early because space is limited! Your tuition of $1,797 includes the day-and-a-half workshop, all workshop materials, continental breakfast each day and lunch on the first day.

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7-9 attendees – 20%

5-6 attendees – 15%

10+ attendees – 25%

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